Study of Low Level Laser Therapy and Tinnitus Relief
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ClinicalTrials.gov Identifier: NCT00845975 |
Recruitment Status :
Terminated
(New information suggested a more effective treatment protocol.)
First Posted : February 18, 2009
Results First Posted : June 5, 2014
Last Update Posted : June 5, 2014
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Tinnitus |
Interventions |
Device: Erchonia Hearing Lasers #1 & #2 Device: Placebo Lasers |
Enrollment | 18 |
Recruitment Details | 18 subjects were recruited and enrolled in this study between August 26, 2008 and September 16, 2008 at a single medical hearing aid clinic. |
Pre-assignment Details | There were no significant events or approaches for the overall study following participant enrollment, but prior to group assignment. There were no enrolled participants excluded from the trial before assignment to groups. |
Arm/Group Title | Erchonia Hearing Lasers #1 & #2 | Placebo Lasers |
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Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site. |
Inactive lasers that do not emit any therapeutic light. Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light. |
Period Title: Overall Study | ||
Started | 9 | 9 |
Completed | 9 | 9 |
Not Completed | 0 | 0 |
Arm/Group Title | Erchonia Hearing Lasers #1 & #2 | Placebo Lasers | Total | |
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Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated. Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light. Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart. Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site. |
Inactive lasers that do not emit any therapeutic light. Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 9 | 9 | 18 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 9 participants | 18 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
5 55.6%
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4 44.4%
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9 50.0%
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>=65 years |
4 44.4%
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5 55.6%
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9 50.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 9 participants | 9 participants | 18 participants | |
60 (9.53) | 66.18 (9.10) | 63.58 (9.55) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 9 participants | 9 participants | 18 participants | |
Female |
6 66.7%
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7 77.8%
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13 72.2%
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Male |
3 33.3%
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2 22.2%
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5 27.8%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 9 participants | 9 participants | 18 participants |
9 | 9 | 18 |
Name/Title: | Louis A Looper, MA, CCC-A |
Organization: | McDonald hearing Aid Centers |
Phone: | 916-218-4100 |
EMail: | llooper@hearingmed.com |
Responsible Party: | Erchonia Corporation |
ClinicalTrials.gov Identifier: | NCT00845975 |
Other Study ID Numbers: |
TS-001 |
First Submitted: | February 16, 2009 |
First Posted: | February 18, 2009 |
Results First Submitted: | April 11, 2013 |
Results First Posted: | June 5, 2014 |
Last Update Posted: | June 5, 2014 |